Prospect: information for the user

RotaTeq oral solution

Rotavirus vaccine (live virus)

Read this prospect carefully before your child is vaccinated because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• If your child experiences adverse effects, consult your doctor or pharmacist even if they are not listed in this prospect. See section 4.

1.What is RotaTeq and how it is used

2.What you need to know before your child receives RotaTeq

3.How to use RotaTeq

4.Possible adverse effects

5.Storage of RotaTeq

6.Contents of the package and additional information

RotaTeq is an oral vaccine that helps protect infants and young children from gastroenteritis (diarrhea and vomiting) caused by rotavirus infection and can be administered to children from 6 weeks to 32 weeks (see section 3). The vaccine contains five types of live rotavirus strains. When the vaccine is administered to a child, the immune system (the body's natural defenses) will create antibodies against the types of rotavirus that appear most frequently. These antibodies help protect against gastroenteritis caused by these types of rotavirus.

Do not use RotaTeq if

• your child is allergic to any of the components of this vaccine (seesection 6. Contents of the pack and additional information).
• your child developed an allergic reaction after receiving a dose of RotaTeq or another rotavirus vaccine.
• your child has had previously intussusception (a bowel obstruction in which a segment of intestine is introduced into another segment).
• your child was born with a gastrointestinal system malformation that could predispose to intussusception.
• your child has any disease that reduces their resistance to infection.
• your child has a severe infection with high fever. It may be necessary to postpone vaccination until recovery. A mild infection such as a cold should not be a problem, but consult your doctor first.
• your child has diarrhea or vomiting. It may be necessary to postpone vaccination until recovery.

Warnings and precautions

Consult your doctor or pharmacist before starting to use RotaTeq, if your child:

• has received a blood transfusion or immunoglobulins in the last 6weeks.
• has close contact with someone, such as a family member, who has a weakened immune system, for example, a person with cancer or taking medications that may weaken the immune system.
• has any gastrointestinal disorder.
• has not been gaining weight and growing as expected.
• or the mother received any medication during pregnancy that weakens the immune system.

If after administration of RotaTeq your child experiences severe stomach pain, persistent vomiting, bloody stools, inflamed abdomen, and/or high fever, contact a doctor/healthcare professional immediately (see also section4 “Possible side effects”).

As always, be careful to wash your hands thoroughly after changing used diapers.

Like other vaccines, RotaTeq does not guarantee complete protection for all vaccinated children, even after the three doses have been administered.

If your child has already been infected with rotavirus, but was vaccinated before becoming ill, RotaTeq may not prevent the disease.

RotaTeq does not protect against diarrhea and vomiting caused by causes other than rotavirus.

Other medicines and RotaTeq

RotaTeq can be administered at the same time as your child receives other normally recommended vaccinations, such as vaccines against diphtheria, tetanus, pertussis (whooping cough),Haemophilus influenzaetype b, inactivated poliomyelitis, oral poliomyelitis, hepatitis B, conjugated pneumococcal vaccine, and conjugated meningococcal group C vaccine.

Inform your doctor or pharmacist if your child is using, has used recently, or may need to use any other medicine (or other vaccines).

Use of RotaTeq with food and drinks

There are no restrictions on food or drink consumption, including breast milk, before or after vaccination with RotaTeq.

RotaTeq contains sucrose

If you have been told that your child has an intolerance to some sugars, inform your doctor or healthcare professional before administering the vaccine.

RotaTeq contains sodium

This vaccine contains 37.6mg of sodium (main component of table salt/for cooking) in each dose. This is equivalent to 1.88% of the recommended daily maximum sodium intake for an adult.

RotaTeq IS ADMINISTERED ONLY ORALLY.

A doctor or nurse will administer the recommended doses of RotaTeq to your child. The vaccine will be administered by carefully pressing the tube and administering the vaccine inside your child's mouth. The vaccine can be administered regardless of food, drink, or breast milk. If your child spits out or regurgitates most of the vaccine dose, a single replacement dose can be administered on the same vaccination visit.

This vaccine must not be injected under any circumstances.

The first dose (2ml) of RotaTeq can be administered from 6weeks of age and must be administered before 12weeks of age (about 3months). RotaTeq can be administered to premature children as long as the pregnancy lasted at least 25weeks. These children must receive the first dose of the vaccine between 6 and 12weeks after birth.

Your child will receive 3doses of RotaTeq administered with at least four weeks of interval between one and another dose. It is essential that your child receives the 3doses of the vaccine to be protected against rotavirus. It is preferable that the three doses are administered before 20-22weeks of age and as late as the three doses must be administered before 32weeks of age.

When administering RotaTeq to your child for the first dose, it is recommended to continue with RotaTeq (and not with another rotavirus vaccine) to complete the vaccination regimen.

If you forgot a RotaTeq dose

It is essential to follow the instructions of your doctor/healthcare professional regarding your child's subsequent visits for the next doses. If you forget or cannot attend your scheduled appointment, consult your doctor/healthcare professional.

Like all vaccines and medications, this vaccine may cause side effects, although not everyone will experience them.

Contact a doctor or healthcare professional immediately if your child experiences one of the following symptoms::

• Allergic reactions (frequency cannot be estimated from available data), which can be severe (anaphylaxis), and may include: allergic inflammation that can affect the face, lips, tongue, or throat.

• Wheezing (rare, may affect up to 1 in 1,000 children): This may present as whistling, coughing, or difficulty breathing.

• Intense stomach pain, persistent vomiting, blood in the stool, inflamed abdomen, and/or high fever.These could be symptoms of a very rare but serious side effect (may affect up to 1 in 10,000 children), called intestinal invagination (a bowel obstruction in which a segment of the intestine folds into another segment).

The following side effects reported with the use of RotaTeq were::

• Very common (may affect more than 1 in 10 children): fever, diarrhea, vomiting

• Common (may affect up to 1 in 10 children): upper respiratory tract infections

• Uncommon (may affect up to 1 in 100 children): stomach pain (see also in the previous paragraph the signs of the side effect intestinal invagination classified as very rare), runny nose, sore throat, ear infection, rash, presence of blood in the stool

• Rare (may affect up to 1 in 1,000 children): urticaria

• Frequency unknown (cannot be estimated from available data): irritability

In children born very prematurely (at 28 weeks of gestation or earlier) longer-than-normal intervals between breaths may occur during the 2 or 3 days following vaccination.

If you want more information about the side effects of RotaTeq, consult your doctor or healthcare professional.

Reporting of side effects

If your child experiences any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect not listed in this leaflet.You can also report them directly through the national notification system included in theAppendix V. By reporting side effects, you can contribute to providing more information about the safety of this medication.

Keep this vaccine out of sight and reach of children.

Do not use this vaccine after the expiration date that appears on the label after EXP (CAD). The expiration date is the last day of the month indicated.

Store and transport refrigerated (between 2°C and 8°C). Store the dosing tube in the outer packaging to protect it from light.

Drugs should not be disposed of through drains or in the trash. Ask your pharmacist how to dispose of containers and unused medications. This will help protect the environment.

Composition of RotaTeq

The active principles of RotaTeq are 5 reassortant human-bovine rotavirus strains:

G12.2 x 106Infected Units

G22.8 x 106Infected Units

G32.2 x 106Infected Units

G42.0 x 106Infected Units

P1A[8]2.3 x 106Infected Units

The other components of RotaTeq are: sucrose, sodium citrate, dihydrogen phosphate monohydrate, sodium hydroxide, polisorbate80, culture medium (containing inorganic salts, amino acids, and vitamins) and purified water.

Appearance of the productand contents of the container

Oral solution

This vaccine is contained in a single-dose vial and is a pale yellow transparent liquid that may have a pinkish tint.

RotaTeq is available in containers of 1 and10single-dose vials.Not all container sizes may be marketed.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder: Merck Sharp & Dohme B.V., Waarderweg 39, 2031 BN Haarlem, Netherlands

Responsible Manufacturer: Merck Sharp and Dohme, B.V., Waarderweg, 39, 2031 BN, Haarlem, Netherlands

For more information about this medicinal product, please contact the local representative of the Marketing Authorization Holder.

Last update of this leaflet:

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu

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This information is intended solely for healthcare professionals:

Instructions

The unused medicinal product and all materials that have come into contact with it will be disposed of in accordance with local regulations.

See also section 3. How to use RotaTeq.